The Effect of a Curriculum-based Physical Activity Intervention on Physical Activity in Schoolchildren

• Sponsor: Teesside University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04119076
• Collaborator: (none)
• Enrollment: 152
• Arms: 2
• Actual Duration (Months): 5.9

Study Details

Study Description

Brief Summary

A non-randomised mixed methods controlled before-and-after study. The study evaluated the effects of a classroom-based physical activity intervention in primary school children on physical activity. Two schools were allocated to deliver the classroom-based intervention for eight weeks, and three schools continued with their usual school routine.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	Other: Classroom-based physical activity; Other: Control Group	N/A

Detailed Description

The primary aim of this study was to test the feasibility and potential effect of a classroom-based, curriculum-embedded intervention - ExCiTE; Exercise Classes in the Teaching Environment- on total physical activity and moderate to vigorous physical activity. The secondary aim was to measure and describe health-related quality of life and physical fitness components, and to gain understanding of the experiences, views and attitudes towards the ExCiTE intervention among participating children and schoolteachers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two school allocated to receive the intervention, three schools allocated to the control groupTwo school allocated to receive the intervention, three schools allocated to the control group
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: The Effect of a Curriculum-based Physical Activity Intervention on Accelerometer-assessed Physical Activity in Schoolchildren: a Non-randomised Mixed Methods Controlled Before-and-after Study
• Actual Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Teacher delivered a 10 minute classroom-based physical activity on school days for eight weeks.	Other: Classroom-based physical activity
Other: Control Group Children in the control schools continued with their usual school routine	Other: Control Group

Outcome Measures

Primary Outcome Measures

1. Amount of time spent in moderate to vigorous physical activity (MVPA) [Accelerometer (ActiGraph GT3X) worn for 7 days. Analysed using Evenson cutpoints.]

   Daily moderate to vigorous physical activity (minutes) collected by wearing an accelerometer for 7 consecutive days.

2. Total physical activity [Accelerometer (ActiGraph GT3X) worn on the hip for 7 consecutive days. Analysed using Evenson cutpoints]

   Total physical activity measured by counts per minute

Secondary Outcome Measures

1. Aerobic Fitness [1 Day of testing]

   Aerobic Endurance. Multistage fitness test

2. Health-Related Quality of Life [Recall questionnaire. Questionnaire completed on one day of testing]

   27 -item KIDSCREEN questionnaire. Assesses health-related quality of life across five dimensions: physical well-being, psychological well-being, parent relations and autonomy, social support and peers and school environment. Likert Scale 1-5. Test completed at baseline, post-intervention and 4 weeks follow up

Other Outcome Measures

1. Fitness Test:Balance [Balance for 30 seconds on each leg. Test completed on one day of testing. Participants balances on one leg on a beam for 30 seconds. The number of times the participants has to put the foot on the floor during the 30 seconds is the score.]

   Flamingo balance test (from Eurofit Protocol). Stand on a wooden beam for 30 seconds and try to balance for 30 seconds. Complete with each foot

2. Fitness Test:Flexibility [Best of three attempts on one day of testing.]

   Sit and reach test. Sit against the sit and reach box, lean forwards and stretch as far forward as possible. Measured to the nearest cm. The higher the number, the better the flexbility.

3. Fitness Test: Speed Fitness Test: Speed [one attempt on one day of testing.]

   10 x 5m shuttle run (from Eurofit Protocol). Run between two cones 5m apart 10 times. The lower the score, the better

4. Fitness Test: Hand Eye Coordination [Best of three attempts, one one day of testing. Time is recorded. The faster the time the better the hand eye coordination]

   Plate tapping - tap the hand on two different colour spots - using the dominant hand.

5. Fitness Test: Explosive Strength [Best of three attempts, one one day of testing. Distance is recorded. The further the distance the better the explosive strength]

   Standing broad jump. Jump as far forwards as possible keeping both feet together. The measurement is taken from the heel on the furthest back landing foot

6. Fitness Test: muscular strength and endurance [One day of testing. The number of sit ups completed in 30 seconds. The higher the number equates to a better performance]

   Sit up on a mat (from Eurofit Protocol)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 11 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Parental Consent

• Child Assent

Exclusion Criteria:

• Respiratory infections; or.

• Condition of injury affecting child's ability to undertake exercise

• Allergic to sticky tape

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Teesside University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alison Innerd, Principal Investigator, Teesside University
• ClinicalTrials.gov Identifier: NCT04119076
• Other Study ID Numbers: TU2019
• First Posted: Oct 8, 2019
• Last Update Posted: Oct 8, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Alison Innerd, Principal Investigator, Teesside University: school-based intervention; active classroom

Study Results

No Results Posted as of Oct 8, 2019